Comparing Immunogenicity with Protein Subunit and mRNA COVID-19 Vaccines in Patients with Rheumatic Diseases on Rituximab (COVBIRD Study)
Bibliographic record
Abstract
Objectives Treatment with rituximab for systemic autoimmune rheumatic diseases (SARD) increases morbidity and mortality following COVID-19 infection,[1] and reduces antibody responses to vaccination. We evaluated humoral responses following fourth or fifth doses of either a protein subunit (PSV) or messenger RNA (mRNA) vaccines. Methods We recruited adults with SARDs on rituximab post-third or fourth mRNA COVID-19 vaccine in an open-label, non-randomized, comparative trial. Participants chose to receive either a fourth dose of mRNA (Spikevax®) or PSV (NuvaxovidTM) vaccines. Patients who already received a fourth dose of mRNA vaccine were offered PSV as their fifth dose. Humoral vaccine-responses were determined pre, 28 days and 6 months post-vaccination. Plasma and sera were evaluated for anti-receptor binding domain (anti-RBD) by ELISA, and for neutralizing antibodies to Wuhan pseudotyped lentiviruses. We used descriptive statistics for demographics and ANOVA for immunogenicity. Results We studied 86 participants with rheumatoid arthritis (39%), ANCA vasculitis (32%), idiopathic inflammatory myositis (9%), systemic lupus erythematosus (8%), systemic sclerosis (7%), and undifferentiated SARDs (4%). Mean (SD) age was 57.3 (15.3); 73% were female; 91% White; 23% were on prednisone, 21% on antimalarials, and 42% on other immunosuppressors. Of those receiving a fourth dose (N=49) more chose Spikevax® (n=35) than NuvaxovidTM (N=14); 37 participants chose NuvaxovidTM for their fifth dose. An increase of anti-RBD response at 28 days post-vaccination was present in those receiving a fourth-dose mRNA vaccine, but not in those receiving fourth-dose PSV (Figure 1). In those receiving fifth-dose PSV, anti-RBD titers decreased at 6 months when compared to those at 28 days, while anti-RBD remained high in fourth-dose mRNA recipients. The fourth-dose mRNA recipients had higher neutralization titers against the Wuhan strain at 28 days compared to their pre-vaccination titers; this was not observed after the fourth dose of PSV. For all groups, the neutralizing response significantly decreased at 6 months post-vaccination compared to day 28. Figure 1 Anti-RBD antibody levels pre-vaccination (day 1) and at 28 days and 180 days post-vaccination . The line and the diamond inside the box indicate the median and the mean, respectively. Outliners are displayed bycirclered (○). Conclusion In SARDs patients on rituximab, both fourth and fifth dose PSV vaccine recipients had decreased anti-RBD titers at 6 months, while post fourth-dose mRNA recipients increased their anti-RBD up to 6 months post-vaccination. Overall, humoral response in mRNA vaccine recipients seemed superior to those receiving PSV. This emphasizes the importance of thorough evaluation of new COVID-19 vaccines in the immunocompromised. [1.] Strangfeld A. Ann Rheum Dis 2021;80:930-42.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".